During setup and implantation of cardiac rhythm management devices, including pacemakers, the attending physician typically connects one or more leads to a pulse generator, inserts the generator into the surgical pocket, and tests the system for proper operation. However, identification of correct lead connection and proper function can be time consuming and frustrating. This is due, in part, to the increased complexity of modern rhythm management devices.
Commonly available cardiac resynchronization systems include three leads, with up to eight electrodes. Advances in technology may increase the number of leads, electrodes, and sensors.
Connector standards, such as low voltage IS-1 (International Organization for Standardization (ISO) 5841-3:2000 Implants for Surgery—Cardiac Pacemakers—Part 3: Low-profile connectors (IS-1) for implantable pacemakers) and high voltage DF-1 (ISO 11318:1993 Cardiac Defibrillators—Connector Assembly DF-1 for implantable defibrillators—Dimensions and test requirements), have been established to differentiate and standardize various connector types. However, newer standards could operate to admit the use of connector ports having low voltage contacts (e.g., from about 1.0 volts to about 10.0 volts) intermixed with high voltage contacts (e.g., up to about 800 volts); such contacts may be substantially similar, or even identical, in appearance and dimensions.
Thus, newer standards, coupled with increased flexibility in rhythm management device design, could eventually permit a number of lead types to be connected to the same contact type within a port. Improper connections might be made more easily. However, if lead connection integrity and functionality were automatically verified prior to surgical closure, the efficacy of implantation operations could be improved.